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Study of BAY 43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer

This study has been completed.

Sponsors and Collaborators: Bayer
ONYX Pharmaceuticals
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00073307
  Purpose

The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY 43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease.


Condition Intervention Phase
Cancer
Renal Cell Cancer (RCC)
Drug: Nexavar (Sorafenib, BAY 43-9006)
Drug: Placebo
Phase III

MedlinePlus related topics:   Cancer   

ChemIDplus related topics:   Sorafenib    Sorafenib tosylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 31 Mar 2007 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate Progression-free Survival (PFS) [ Time Frame: 31Dec2005 ] [ Designated as safety issue: No ]
  • To evaluate the best overall response rate [ Time Frame: 31Mar2007 ] [ Designated as safety issue: No ]
  • To assess changes in the patient's health-related [ Time Frame: 30Sep2007 ] [ Designated as safety issue: No ]
  • To determine overall response duration and time to objective response [ Time Frame: 30Sep2007 ] [ Designated as safety issue: No ]
  • To determine overall disease control rate [ Time Frame: 30Sep2007 ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 30Sep2007 ] [ Designated as safety issue: Yes ]

Estimated Study Completion Date:   August 2009

Arms Assigned Interventions
Arm 2: Placebo Comparator Drug: Placebo
Placebo
Arm 1: Experimental Drug: Nexavar (Sorafenib, BAY 43-9006)
Multi Kinase Inhibitor

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Patients with unresectable and/or metastatic, measurable renal cell carcinoma histologically or cytologically documented
  • Patients must have had one prior systemic therapy for advanced disease, which was completed at least 30 days but no longer than 8 months prior to randomization
  • Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST)
  • Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1
  • Patients who have adequate coagulation, liver and kidney functions

Exclusion Criteria:

  • Patients with rare subtypes of renal cell carcinoma (RCC) such as pure papillary cell tumors, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumors
  • Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma,or superficial bladder tumors, or other malignancies curatively treated > 2 years prior to entry
  • Cardiac arrhythmias requiring anti-arrhythmics, symptomatic coronary artery disease or ischemia or congestive heart failure
  • Patients with a history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
  • Patients with a history or presence of metastatic brain or meningeal tumors
  • Patients with seizure disorder requiring medication (such as anti-epileptics) History of organ allograft or bone marrow transplant of stem cell rescue
  • Patients who are pregnant or breast-feeding Women of childbearing potential must have a negative pregnancy test prior to drug administration. Both men and women enrolled in this trial must use adequate birth control
  • Patients who have three or more of the following:

    1. ECOG performance status greater than or equal to 2,
    2. Abnormally high lactate dehydrogenase,
    3. Abnormally high serum hemoglobin,
    4. Abnormally high corrected serum calcium,
    5. Absence of prior nephrectomy

Excluded therapies and medications, previous and concomitant:

  • Concurrent anti-cancer chemotherapy, immunotherapy or hormonal therapy except biphosphonates
  • Significant surgery with 4 weeks of start of study
  • Investigational drug therapy during or within 30 days
  • Concomitant treatment with rifampin or St. John's Wort
  • Prior use of Raf-kinase inhibitors (RKI), MEK or Farnesyl transferase inhibitors
  • Prior use of Bevacizumab, and all other drugs (investigational or licensed) that target VEGF/VEGF receptors
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073307

Show 19 study locations  Show 19 Study Locations

Sponsors and Collaborators
Bayer
ONYX Pharmaceuticals

Investigators
Study Chair:     Study Chair Bukowski, M.D.     Cleveland Clinic Cancer Center, Cleveland, Ohio, USA    
Study Chair:     Study Chair J Escudier, MD     Institut Gustave Roussy (IGR), Villejuif, France    
  More Information

#PL#N. Engl. J. Med. 356 (2) 125- 134 (2007) ISSN:0028-4793  This link exits the ClinicalTrials.gov site
 
#PL#PubMed.  This link exits the ClinicalTrials.gov site
 
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
 
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site
 

Publications indexed to this study:

Responsible Party:   ( Bayer HealthCare AG, Therapeutic Area Head )
Study ID Numbers:   11213
First Received:   November 19, 2003
Last Updated:   December 31, 2007
ClinicalTrials.gov Identifier:   NCT00073307
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Urogenital Neoplasms
Renal cancer
Urologic Neoplasms
Kidney cancer
Carcinoma
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Sorafenib
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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